Johnson & Johnson

Life threatening symptom reports

Female, 16 - 25 years

Age Reported Symptoms Notes
17 2021-03-27 anaphylactic shock blisters on the tongue, followed by itching, and anaphylactic shock from 11:30pm to 12:30am. benadry... Read more
blisters on the tongue, followed by itching, and anaphylactic shock from 11:30pm to 12:30am. benadryl and 2 epi pens were used and then at the hospital steroids and IV benadryl were utilized. Benadryl was used for the next 24 hours and then steroids were prescribed outpatient
18 2021-03-16 pulmonary embolism On 3/14/21 patient started with left flank pain that radiated to left shoulder and increased pain wh... Read more
On 3/14/21 patient started with left flank pain that radiated to left shoulder and increased pain while taking a deep breath. Mother called on 3/16/21 and patient was seen in primary clinic for issue. She had labs and xray done. Xray showed possible mild opacity in left lower lobe and to do ct scan. Ct pe study done same day showing bilateral lower lung pulmonary emboli and lower lung patchy infiltrates. Patients pain progressively got worsened and was seen in the er to be transferred to outgoing facility for care.
18 2021-04-09 excessive bleeding Pt received vaccine, while walking to recovery became dazed, confused, unsteady on feet. Staff held... Read more
Pt received vaccine, while walking to recovery became dazed, confused, unsteady on feet. Staff held her and guided her to floor to lie down put feet up. MD assessed summized vagal vasal response. No LOC, No SOB. pt did not hit her head. Applied ice to back of neck, gave water for hydration. VS146/84, HR 60 reg, resp 12, SpO2 97% Pt's . Left Deltoid site benign - reddness - swelling -bleeding. Mother was at her side. stated "she has a problem with needles this happens to her". Provided reassurance. Monitored 30 minutes. kept reassessing condition. Pt stated she felt better. Ok'd to exit with family after 30 minutes. 4/10/21 next day tried to contact x 2 to check on condition , no answer left message, no return call back
18 2021-04-12 blood clot Flu-like symptoms. Muscle cramping in the left leg. Continuos period with heavy blood clotting.
18 2021-04-13 blood clot multiple large blood clots from her nares on Monday 4/12
18 2021-05-02 pulmonary embolism Was was pain in calf area and having a hard time breathing and very tired.. went to doctor on 4/20... Read more
Was was pain in calf area and having a hard time breathing and very tired.. went to doctor on 4/20/2021 Doctors Diagnosed with Pulmonary Embolism
18 2021-05-11 deep vein blood clot Deep venous thrombosis involving the common femoral vein and central portions of both superficial a... Read more
Deep venous thrombosis involving the common femoral vein and central portions of both superficial and deep femoral veins. Thrombus is also present within the saphenous vein. symptoms- leg swelling and pain since 5/2/21
18 2021-05-28 vaginal haemorrhage localized swelling. Also reported vaginal bleeding--in the 3 days after vaccine, decreased by visit
18 2021-06-19 respiratory arrest Patient experienced fatigue, nausea and 105 degree fever approximately 10 hours after the vaccine sh... Read more
Patient experienced fatigue, nausea and 105 degree fever approximately 10 hours after the vaccine shot. The next morning at the breakfast table she began crying and shouting that she had lost her vision and everything went dark. Within minutes she stopped breathing and her eyes rolled back in her head. Her body went rigid and her mother caught her as she was falling backward in her chair. Her skin was white and her lips blue. I administered CPR and after approximately 4 mouth to mouth breathes she began breathing again. When she regained conciousness she said she could not hear. The paramedics arrived and tended to her.
18 2021-06-21 excessive bleeding PATIENT RECEIVED JANSSEN VACCINE AND FELT FINE BUT WHILE WAITING FOR THE 15 MINUTE TIME PERIOD AFTER... Read more
PATIENT RECEIVED JANSSEN VACCINE AND FELT FINE BUT WHILE WAITING FOR THE 15 MINUTE TIME PERIOD AFTER SHE PASSED OUT AT 11:57 AM AND FELL FROM THE CHAIR TO THE FLOOR AND HIT HER HEAD CAUSING A WOUND ABOVE HER LEFT EYEBROW WITH SIGNIFICANT BLEEDING. 911 WAS CALLED AS WELL AS THE PATIENTS MOTHER WHO WAS STILL IN THE STORE. HER MOTHER CAME OVER IMMEDIATELY AND EMS ARRIVED AT 12:15 PM AND TOOK HER TO THE HOSPITAL FOR EVALUATION. WHILE WAITING FOR EMS WE GAVE THE PATIENT MOIST AND DRY PAPER TOWELS UPON REQUEST AS WELL AS SEVERAL SMALL CONE CUPS OF WATER AND THEN A WATER BOTTLE. EMS LEFT WITH THE PATIENT AT 12:24 PM.
18 2021-07-08 cerebrovascular accident Seizure secondary to 5 cortical strokes that happened within 1 month of the vaccine
18 2021-07-19 excessive bleeding, respiratory arrest I began feeling weak and fluey around 8:30 or 9:00 pm. I decided to go to sleep around 10, noticed m... Read more
I began feeling weak and fluey around 8:30 or 9:00 pm. I decided to go to sleep around 10, noticed my fingers had turned yellow and lost all circulation. I went downstairs to ask my dad what to do, and immediately felt like I was going to faint. Sat down on a chair and put my head between my legs, but passed out as I was doing so, and fell on the floor. According to onlookers (brother and sister, who is an EMT) I was convulsing and stopped breathing for about thirty seconds, and my eyes were glassy and rolling. I woke up to my sister telling me to breathe. There was blood on the floor (I had hit my face on the way down) and I was trembling uncontrollably and had wet myself. I was awake and aware of my surroundings, and remembered everything up to and including sitting sitting on the chair before I passed out. My brother had called 911 while I was out and an ambulance came within five minutes. The paramedics put me in the ambulance and took me to the hospital (they would have taken me to local except there was risk that it was a seizure, which I guess local isn't equipped to handle). They measured my vital signs, made IV ports in my arms and drew some blood. My blood pressure was super low and my heart rate was super high, and I had a temperature of 102. When I got to the hospital they put two liters of saline drip into me to rehydrate me, did a CAT scan, and some bloodwork. They discharged me around 3:30 AM on Monday morning, told me to stay hydrated and get a lot of rest. I slept all day yesterday (Monday) and was feverish and weak. By today (Tuesday) I think I have mostly recovered.
19 2021-03-15 grand mal seizure Seizure, grand mal, lasted 10 seconds, postictal up to 10 minutes
19 2021-04-05 excessive bleeding Pt reported feeling dizzy after receiving IM injection and has (+) LOC less than 30 seconds, unsure ... Read more
Pt reported feeling dizzy after receiving IM injection and has (+) LOC less than 30 seconds, unsure if hit head, head atraumatic without abrasions, lacerations, bleeding. Pt was assisted to a recumbent position with BLEs elevated. VS as follows: BP 122/70, HR 78, sats 97% on RA. Pt was given water and snack bar and recovered within 15 mins. She ambulated out of clinic in NAD and was driven home by roommate.
19 2021-04-08 vaginal haemorrhage About an hour after I received my vaccination, I started having some uterine cramps and when I got h... Read more
About an hour after I received my vaccination, I started having some uterine cramps and when I got home about 2 hours after I got my vaccine, I had some vaginal bleeding. Later on in the day, there was a little bit more but not as much as the first time. My last period was almost 2 weeks ago.
19 2021-04-12 cerebrovascular accident Patient presented to hospital on 4/9/21 - 4 days post vaccination - with new onset left sided weakne... Read more
Patient presented to hospital on 4/9/21 - 4 days post vaccination - with new onset left sided weakness. Brain CTA showed a M1 branch occlusion. Patient was given TPA and transferred to Medical Center for further management and mechanical thrombectomy. Successful thrombectomy done. Etiology of stroke cryptogenic but suspect emoblic event. Questionable moyamoya disease - notes state "if moyamoya suspect, patietn will get neurosurgery survice on board/appreciate neuro recommendations"
19 2021-04-13 cerebrovascular accident Had a stroke, left side affected. Received TPA upon hospital arrival
19 2021-04-13 blood clot On 4/8/2021 I developed a headache after receiving the Johnson and Johnson vaccine. I took the next ... Read more
On 4/8/2021 I developed a headache after receiving the Johnson and Johnson vaccine. I took the next few days easy, and laid in bed for the majority of the weekend. On 4/10/2021 I left my residence to get dinner and noticed I was short of breath just walking from the building to my car. The shortness of breath worsened over the next few days. On 4/13/2021 I called a clinic and told them I had been short of breath and they directed me to the ER. I arrived to the ER around 2:30 in the afternoon. They ordered a chest x-ray and ran a test to determine if I could have a blood clot. The test came back with results indicating I could have a blood clot, so they did a chest CT and an MRI. The chest CT showed a blood clot in my left pulmonary artery. They prescribed a blood thinner, told me to stop taking oral birth control, and discharged me.
19 2021-04-23 blood clot Patient stated she needed to go to hospital for adverse reaction of pain in leg. After asking MD to... Read more
Patient stated she needed to go to hospital for adverse reaction of pain in leg. After asking MD to check her leg, they discovered a blood clot per patient. She is now doing well per her.
19 2021-06-02 cardiac arrest Pt called 911 for shortness of breath The following is the paramedic narrative patient found at home... Read more
Pt called 911 for shortness of breath The following is the paramedic narrative patient found at home, sitting on floor. alert, speaking. Patient with sob, saying she can not breath , states it came on suddenly about a half hour ago and pt has not been feeling ill prior to this. No trauma, no pains or other complaints. pt went unconscious then into pea cardiac arrest, witnessed. Laid pt down and check for heart beat and breathing, became pulseless and apneic Initial treatment CPR, IV, BVM. Family states no medical history other than anemia. no drug use, no respiratory or cardiac issues. Pt was given J and J covid 19 vaccine recently. Pt also just returned from a trip and noted to not have gone diving. 2 epinephrine IV given on scene with no change to heart rhythm. Pt loaded into the ambulance and cpr continued while transporting. pt with copious amounts of vomit, suction enroute to ed. Pt w/o shockable rhythm throughout transport. Continue cpr and bvm via king airway , cap at 9. unable to get capnography higher. no change in heart rhythm. while enroute to er. At ED pt did get pulses back however it was reported that pt loss pulses and was pronounced
19 2021-06-07 grand mal seizure GRAND MAL SEIZURE; This spontaneous report received from a parent concerned a patient of 19-year-old... Read more
GRAND MAL SEIZURE; This spontaneous report received from a parent concerned a patient of 19-year-old female. The patient's weight was 210 pounds, and height was 170 centimeters. The patient's past medical history included seizures, drop blood pressure, and pulse drop, and concurrent conditions included borderline personality, bipolar disorder, cigarette smoker, non-alcohol user, marijuana user, and memory loss, and other pre-existing medical conditions included patient had no known allergies. The patient had no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 03-JUN-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, at 7 pm the patient complained of being very tired, she felt that she was passing out and nauseated. At 3 am in morning (04-JUN-2021), patient started to have a grand mal seizure, lied on the floor, totally confused, her eyes went all over the place, she did not remember all the people around her. Based on description patient had memory loss, she could not remember the last 3 years of her life and she was on year between 2017 and 2018. Patient had a history of seizure last 2017 when she was on a psychotropic medication (Topamax) which she was taking because of her bipolar disorder. Medication which was taken for bipolar disorder causes her to drop her blood pressure and pulse which resulted to seizure. Patient was planning to visit doctor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from grand mal seizure. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210611850-COVID-19 VACCINE AD26.COV2.S-Grandmal seizure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
19 2021-07-19 blood clot Blood clot in left leg
20 2021-04-22 vaginal haemorrhage Onset of period was delayed by 8 days - this is highly unusual as periods are normally very regular.... Read more
Onset of period was delayed by 8 days - this is highly unusual as periods are normally very regular. When period began, it was incredibly heavy and contained clots of blood. Accompanied by significant abdominal pain and cramping with nausea. Also, the blood was bright red (normally it is dark brownish red).
20 2021-04-22 vaginal haemorrhage I am on birth control and am not supposed to have a period. I had vaginal bleeding a few days after ... Read more
I am on birth control and am not supposed to have a period. I had vaginal bleeding a few days after receiving the vaccine. It is still occurring over a week later.
20 2021-05-19 respiratory arrest Patient had a vasovagal response and fainted a few minutes after her injection. She was unconscious... Read more
Patient had a vasovagal response and fainted a few minutes after her injection. She was unconscious, not breathing for a few seconds as her head fell to her chest, but resumed breathing when we opened her airways. Her body seized upon taking in air and 911 was called. She regained consciousness before the paramedics arrived and her vitals were within normal limits when they checked her. Pt went home on her own with mom.
20 2021-06-08 anaphylactic reaction Anaphylaxis as a result of COVID-19 vaccination. Chest pain, chest burning, swollen tongue, nausea, ... Read more
Anaphylaxis as a result of COVID-19 vaccination. Chest pain, chest burning, swollen tongue, nausea, dizziness, lightheadedness.
20 2021-06-17 cerebral haemorrhage, brain sinus blood clot 6/1 She woke up with a severe headache and vomiting. She went to the urgent care and was treated for... Read more
6/1 She woke up with a severe headache and vomiting. She went to the urgent care and was treated for migraine headache and nausea. She was giving medication for pain and vomiting. Slept until the next day. Felt somewhat better the next day and continued meds. She went to work on 6/3 and towards the end of her shift she told her boss about the severe headache and sat in her car outside and then became unresponsive. The paramedics were called and she was transferred to the hospital and diagnosed with a brain blood clot and brain bleeding. She was flow by air car to another hospital and admitted to ICU. She was in Neurology ICU until 6/6, and then transferred to a normal neurology bed and released on 6/11. Diagnosis of left venous sinus thrombosis and hemorrhage in the left temporal lobe.
21 2021-04-14 vaginal haemorrhage Two days after receiving the Johnson & Johnson vaccine, the patient (myself) awoke in the middle of... Read more
Two days after receiving the Johnson & Johnson vaccine, the patient (myself) awoke in the middle of the night with painful cramps in the lower abdomen. She got up in the morning to some blood in her underwear. The next day, she awoke to an immense of amount of blood coming out of her vagina to the point it was dripping down her leg. For context, the patient received the Mirena IUD several months ago and had not had a period since receiving the IUD, besides spotting. This is why these events were startling since she had not had a period in several months and this immense bleeding and cramping was abnormal to her. As of today (4/15/2021), she has been experiencing heavy bleeding for 5 days. Again, this is very abnormal to her since she has not experienced a period for several months.
21 2021-04-20 deep vein blood clot Acute deep vein thrombosis (DVT) of right peroneal vein
21 2021-04-22 deep vein blood clot Patient developed calf pain 4 days prior to her ER presentation on 4/22/2021. Found to have an occlu... Read more
Patient developed calf pain 4 days prior to her ER presentation on 4/22/2021. Found to have an occlusive DVT of the left posterior tibial vein.
21 2021-04-28 grand mal seizure Hepatitis / Encephalopathy (seizures, ADEM, MISC/A) PRESENTING PROBLEM: Fever and chills [R50.9] He... Read more
Hepatitis / Encephalopathy (seizures, ADEM, MISC/A) PRESENTING PROBLEM: Fever and chills [R50.9] Hepatitis [K75.9] Febrile illness, acute [R50.9] Acute nonintractable headache, unspecified headache type [R51.9] Seizure (HCC) [R56.9] MIS-C associated with COVID-19 (HCC) [M35.81] Active Issues Requiring Follow-up MIS-C/A - 2/2 COVID-19 infection vs idiosyncratic reaction to J&J vaccine -prednisone taper over 16 days as above -ID will be arranging follow up serial labs (CBC with diff, CMP, Ferritin level, CRP, LDH) -Bactrim prophylaxis while on steroids -Acyclovir 400 mg BID for prophylaxis (hx of recurrent HSV infection of eyelid) - duration to be clarified by ID at follow up -ASA 81 mg daily -TTE w/ normal coronaries. She will need cardiac MRI, to be arranged by adult congenital cardiology Generalized tonic-clonic seizures - witnessed and captured on EEG 4/9. No further events. Continue Keppra 1500 mg BID. outaptient f/u with neurology Abnormal MRI brain - diffuse T2 white matter hyperintensities - non-specific. She will need follow up MRI brain w/ and w/o contrast in 1 month and follow up with neurology clinic ADHD - given insomnia, Senthuri was recommended to avoid vyvanse for now. She will discuss with her outpatient prescriber Anxiety and depression - zoloft increased to 125 mg daily Insomnia - 2/2 trauma from critical illness. Improved with trazodone HS. Elevated EBV PCR - ID will continue to monitor. Nausea/vomiting - resolved. Likey 2/2 gastritis in setting of steroid use. PPI BID x 4 weeks DISCHARGE DISPOSITION: Home without services
21 2021-05-11 blood clot For thirty-six hours after the vaccine. I had body aches and chills and my eye sockets were sore and... Read more
For thirty-six hours after the vaccine. I had body aches and chills and my eye sockets were sore and it hurt to look up. Ten days after the vaccine I was in the shower and a large blood clot came out of my nose. It was a large clot about the size of a quarter and there was no other blood with it. The clot came out of my left nostril but it was not like a nose bleed. I went to the Urgent Care but they did not do tests.
21 2021-05-13 severe muscle breakdown Myalgias for 17 hours on day of vaccination that completely resolved. Myalgias and weakness started... Read more
Myalgias for 17 hours on day of vaccination that completely resolved. Myalgias and weakness started 4/15 and continued progressively for a week before presenting to the clinic. Lab results showed rhabdomyolysis with CPK of 204,900 U/L and elevated transaminases (see levels below). Referred to Emergency Department where she was admitted to the hospital for IV fluids. Creatinine never increased and CPK/transaminases trended downward until release from hospital. At clinic follow up visit on 5/6, patient reported resolution of pain and weakness although she doesn't quite feel 100%.
21 2021-05-31 deep vein blood clot Patient developed a deep vein thrombosis approximately one month after receipt of vaccine. Of note,... Read more
Patient developed a deep vein thrombosis approximately one month after receipt of vaccine. Of note, was on an oral contraceptive prior to this. No other history of VTE or smoking, or other coagulation disorders in family.
21 2021-06-02 pulmonary embolism Pulmonary embolism on 5/26/21 - tested positive for Covid in emergency room after diagnosing pulmona... Read more
Pulmonary embolism on 5/26/21 - tested positive for Covid in emergency room after diagnosing pulmonary embolism. No symptoms of Covid until lung pain from embolism began. Hospitalized for 3 days treating PE and prescribed blood thinners for at least 6 months to prevent potential reoccurrence.
21 2021-06-26 blood clot Blood Clots, 5:20 PM, 7 hours Abdominal Pain, 5:00 PM, 7 hours Tiredness, 5:00 PM, 7 hours Back Pai... Read more
Blood Clots, 5:20 PM, 7 hours Abdominal Pain, 5:00 PM, 7 hours Tiredness, 5:00 PM, 7 hours Back Pain, 6:50 PM, 5 hours
22 2021-04-08 grand mal seizure Tonic/Clonic seizure, 2 in a row. Hx of seizures.
22 2021-04-14 anaphylactic reaction Prolonged tingling/burning pain in left leg from above knee to toes. Could not be relieved by any po... Read more
Prolonged tingling/burning pain in left leg from above knee to toes. Could not be relieved by any position sitting or lying down. Movement of ankle, toes, or leg in general caused pain to extend up to the hip and become much sharper. Relieved by 3 Aspirins
22 2021-04-17 severe muscle breakdown Vaccine received 4/7/2020. On Wednesday 4/14/2020, pt went to the gym and did high intensity interva... Read more
Vaccine received 4/7/2020. On Wednesday 4/14/2020, pt went to the gym and did high intensity interval training involving body weight exercises, specifically an exercise called "v-ups". Exercise was not more strenuous than usual, and pt was well hydrated. Pt reports that she exercises often and this was not a new exercise. Soon after workout, pt began having muscular pain in the hip, radiating into her inner thighs bilaterally with associated tingling. On 4/15, pain worsened and pt had difficulty ambulating. Denies any edema, erythema in her legs or unilateral leg swelling. Presented to the ED on 4/16 and found to have elevated CK of 127,768 with UA significant for large blood and protein, without RBC, indicative of rhabdomyolysis. Pt did not have any known risk factors that may precipitate rhabdomyolysis. On admission, fluids were initiated with downtrending CK, LFTs, and renal function remained stable. er D&C was done at on 4/2 and she reports there were no complications during or after the procedure. Her BHCG was elevated at the time and she tried an oral abortion pill but still had some fetal remnants so went for a D&C. She had the J&J vaccine shortly after on 4/7 and she reports no complications around and shortly after getting the vaccine. Denies vaginal bleeding or odor. Denies fevers, chills, abd pain, diarrhea, constipation, dysuria, chest pain, palpitations, shortness of breath, nausea/vomiting.
22 2021-05-07 vaginal haemorrhage C/O irregular vaginal bleeding x 3 weeks; resolved spontaneously Pt has always had regular periods, ... Read more
C/O irregular vaginal bleeding x 3 weeks; resolved spontaneously Pt has always had regular periods, never with breakthrough/intermenstrual bleeding
22 2021-05-11 anaphylactic shock Received the following text message from the mother of the patient: Patient was airlifted to the ho... Read more
Received the following text message from the mother of the patient: Patient was airlifted to the hospital where she is living. She had the J&J vaccine yesterday and went into anaphylactic shock. She pretty much always been allergic to everything. They put her on a high does of steroids but was just wondering if you had heard any reactions like that. Said it could take up to 6 weeks to settle in her system. She's fine now.
22 2021-05-16 low platelet count Patient admitted for left flank pain. Was treated for urinary tract infection, although never had s... Read more
Patient admitted for left flank pain. Was treated for urinary tract infection, although never had symptoms of a UTI. No dysuria, frequency or urgency. Urine is dark. Irregular menses. Has had cough, sore throat, vomiting, headache over past week. Mild epistaxis and heavy menses last month. CBC shows anemia and thrombocytopenia. Imaging showed splenomegaly with small acute splenic infarct. Hematology/oncology consulted and TTP ruled out.
22 2021-05-19 anaphylactic shock ANAPHYLACTIC SHOCK; This spontaneous report received from a company representative concerned a 22 ye... Read more
ANAPHYLACTIC SHOCK; This spontaneous report received from a company representative concerned a 22 year old female. The patient's height, and weight were not reported. The patient's past medical history included anaphylactic reaction with unknown cause. The patient had no known allergies. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry date were Unknown) dose was not reported, 1 total, administered on 11-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 11-MAY-2021, the patient experienced anaphylactic shock, and was hospitalized and given high dose of steroids to manage adverse reaction. Patient was discharged on the same day (11-MAY-2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from anaphylactic shock. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210523394-COVID-19 VACCINE AD26.COV2.S-Anaphylactic shock. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
23 2021-04-13 cerebrovascular accident Patient received 1 dose of the vaccine on 3/29/21. 13 days later on 4/10/21 the patient presented ... Read more
Patient received 1 dose of the vaccine on 3/29/21. 13 days later on 4/10/21 the patient presented to Hospital with an acute stroke. Patient was working out with her mother and collapsed. She presented to the ED with aphasia, right sided weakness, right nick pain and a left gaze preference. CT in the MSU was negative therefore IV tPA was given. Patient is recovering but still admitted to the Neuro ICU.
23 2021-05-23 death presented to ED dept confused, incr n/v, weakness. Received palliative carex4 days. deceased 05/24
23 2021-06-10 pneumonia Patient did not feel well after receiving vaccination. Indicated that she developed a cough, shortn... Read more
Patient did not feel well after receiving vaccination. Indicated that she developed a cough, shortness of breath and increased respirations and pulse. She admitted to the hospital on 6/8/21 and was diagnosed with pneumonia.
24 2021-03-13 anaphylactic reaction Patient developed shortness of breath, tachycardia, epigastric and chest pain. A thorough workup was... Read more
Patient developed shortness of breath, tachycardia, epigastric and chest pain. A thorough workup was performed to search for other causes and none was found, ultimately patient was treated as moderate anaphylaxis, symptoms improved with fluids, steroids, benedryl, and she was discharged with strict return precautions and outpatient followup.
24 2021-03-24 vaginal haemorrhage vaginal bleeding. Pt reports LMP 28Feb and started having vaginal bleeding on 12Mar and has variabl... Read more
vaginal bleeding. Pt reports LMP 28Feb and started having vaginal bleeding on 12Mar and has variable light to heavier bleeding since then. patient also received J&J COVAX yesterday and has fever,and headache, reports improvement with excedrin. 24 yo f c/o ongoing vaginal bleeding w/clots x1wk w/irregular menstrual cycle timing; Pt states LMP 28FEB2021, states was regular w/o heavy flow; Pt states approx 7d ago sudden onset of vaginal bleeding, however tapered off slowly over next several days, then increased again this AM, states has used 1x pad over last 4hrs; Pt states mild abd cramping radiating to lower back b/l, c/w sx's experience during child birth; Pt denies any fevers/ns/chills, nvd, urinary sx's
24 2021-04-12 vaginal haemorrhage Vaginal bleeding like period day after vaccine and lingering headache since vaccine and currently. S... Read more
Vaginal bleeding like period day after vaccine and lingering headache since vaccine and currently. Some shortness of breath inconsistently
24 2021-04-14 blood clot Site: Pain at Injection Site-Mild, Systemic: Blood Disorder (diagnosed by MD)-Medium, Systemic: Diz... Read more
Site: Pain at Injection Site-Mild, Systemic: Blood Disorder (diagnosed by MD)-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: blood clots in stool-currently under care of primary care physician for clot formation investigation-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Unable to Sleep-Medium, Systemic: Weakness-Medium, Additional Details: patient reported blood clots in stool on 4/11/21 and 4/12/21. Patient was flushed, dizzy and faint after clot was found. Patient has no significant history of hemorriods or colorectal conditions.
24 2021-05-16 pulmonary embolism The patient presented with chest pain on 5/15/2021. She had a 9 hour drive on 4/30/2021, and had the... Read more
The patient presented with chest pain on 5/15/2021. She had a 9 hour drive on 4/30/2021, and had the J&J vaccine on 4/11/2021.
24 2021-05-18 vaginal haemorrhage A couple hours after getting the J&J vaccine, I experienced extreme cramping and a light/medium flow... Read more
A couple hours after getting the J&J vaccine, I experienced extreme cramping and a light/medium flow of blood from my vagina. The cramps were very painful - on a scale of 1 to 10, an 8. I have been bleeding ever since. Sometimes there will be only be a drop or two of blood that comes out for a couple hours but usually it is much more than that. It's like I'm on my period, but I am not. I have an IUD and also am on the birth control pill (Junel). I am not on the placebo week on my birth control pill pack, so I should not be experiencing a period right now, but ever since the shot, I have been bleeding and experiencing intense cramps and pain since.
24 2021-05-31 blood clot BLOOD CLOT; This spontaneous report received from a consumer concerned a 24 year old female. The pat... Read more
BLOOD CLOT; This spontaneous report received from a consumer concerned a 24 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, therapy start date were not reported, with frequency 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in APR-2021, the patient experienced blood clot and was hospitalized (date unspecified) and it was reported caller said his brother would called to provide more information regarding the patient's case. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210552268-COVID-19 VACCINE AD26.COV2.S-BLOOD CLOT. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
24 2021-07-19 death, blood clot in the brain, deep vein blood clot, blood clot in lung, cerebral haemorrhage Lower extremity deep vein thromboses, pulmonary thromboses, cerebral thromboses and hemorrhage, deat... Read more
Lower extremity deep vein thromboses, pulmonary thromboses, cerebral thromboses and hemorrhage, death
25 2021-04-08 anaphylactic reaction Dizziness, Lightheadedness, right throat started after 2 minutes and continued to get worse. Altered... Read more
Dizziness, Lightheadedness, right throat started after 2 minutes and continued to get worse. Altered consciousness began. Anaphylaxis started approximately 25 minutes after vaccine.
25 2021-04-11 grand mal seizure 1 minute after receiving vaccine, patient was seated in a chair. Large sigh, then head went back. ... Read more
1 minute after receiving vaccine, patient was seated in a chair. Large sigh, then head went back. Staff immediately by her side, full grand mal seizure lasting 90 seconds. During this time assist of two to floor. After seizure assisted to side for rescue position. Public health attached to hospital and MD and PA arrived quickly. Patient transported to ER for further follow up. When patient regained consciousness she stated she had "passed out several times before and has felt more stress in this past year."
25 2021-04-12 vaginal haemorrhage Menstrual bleeding started about 2 hours later. Fever, chills, aches, joint pain, sharp headache, ar... Read more
Menstrual bleeding started about 2 hours later. Fever, chills, aches, joint pain, sharp headache, around that afternoon at 7PM. Fever and chills went away after 24 hours. Joint pain and stabbing headache remained for about 48. Currently still bleeding on day 5 and getting occasional sharp headache pains that last around 5 minutes and go away for hours. Joints still feel a lingering ?soreness? almost. Last night, day 4 the cramps that accompanied the bleeding intensified greatly and were very painful. Today I have much more ?period like? cramping still. Previously cramps were there but minimal and occasional.
25 2021-04-20 low blood platelet count 25 yo G2P0 @ 37+1 pregnant with longstanding immune thrombocytopenia purpura with a routine CBC show... Read more
25 yo G2P0 @ 37+1 pregnant with longstanding immune thrombocytopenia purpura with a routine CBC showing PLTs of 56 down from 119 1 month ago. Had J&J vaccine on 4/9. - Lab repeated and confirmed - D/w MFM and Hematologist. In an abundance of caution, will get coags, CMP, and P/cr urine ratio to evaluate for HELLP. Will also get HIT antibodies to evaluate for possibility of Vaccine induced thrombocytopenia(VIT). - Will plan on treating with Dexamethasone 40mg Daily x 4 days to increase platelet count. D/w hematologist, and he will see the patient and run the test for HIT antibodies (PF-4) and initiate IVIG treatment, which would help treat the low platelets either from exacerbation of ITP or VIT. If these come back positive, will likely transfer patient to HN for admission and delivery to be followed by therapeutic anticoagulation with non-heparin based therapy, consistent with usual therapy for HIT.
25 2021-04-20 blood clot Adverse event: Ischemic Colitis most likely from a blood clot Symptoms: stomach pain -> severe diarr... Read more
Adverse event: Ischemic Colitis most likely from a blood clot Symptoms: stomach pain -> severe diarrhea -> diarrhea of only blood, no stool for 24 hrs Symptoms began Saturday after vaccination (which was administered Thursday afternoon) Treatment: hospitalization, steroids, antibiotics
25 2021-04-21 cerebral haemorrhage, deep vein blood clot admitted to hospital that evening with acute intracerebral hemorrhage felt to be from a cerebral ven... Read more
admitted to hospital that evening with acute intracerebral hemorrhage felt to be from a cerebral venous thrombosis with dense left hemiplegia. one week later, developed bilateral upper extremity cephalic vein thrombosis that the following week, 4/21/21, continued to propagate
25 2021-05-20 low blood platelet count About a week and a half after receiving the first and only dose of the Johnson and Johnson Covid-19 ... Read more
About a week and a half after receiving the first and only dose of the Johnson and Johnson Covid-19 vaccine, I developed small bruises (Petechiae) on my chest and arm. I decided to consult my doctor just in case. My doctor did a blood draw and ran a CBC panel. The next day I was rushed to the ER as my platelet count was reported at 7. By the time I got to the ER my platelets had dropped even further to a count of 2. I was treated inpatient for 3 days 2 nights. At this time I was diagnosed with IPT (Immune Thrombocytopenia Purpura). It was treated with two rounds of IVIG (Intravenous immunoglobulin) and 75 mg of Prednisone daily (which I have been slowly tapering off of since). My platelets restored to a non-critical level and have continued to hold steady ever since.
25 2021-05-26 vaginal haemorrhage The morning after I received my vaccine I began to have unexpected vaginal bleeding. The Jolessa bir... Read more
The morning after I received my vaccine I began to have unexpected vaginal bleeding. The Jolessa birth control that I am taking allows me to skip my periods by continuing to take the active pills nonstop and skip the placebo pills, so this bleeding was unexpected, as I do not have a regular period or ?withdrawal bleed? on a regular basis. The bleeding has not stopped and has been consistently a moderate-heavy flow, going on 20 days straight now.
25 2021-05-31 deep vein blood clot Approximately two weeks after receiving the vaccine (4/19/21), I was taken to the hospital in an amb... Read more
Approximately two weeks after receiving the vaccine (4/19/21), I was taken to the hospital in an ambulance. I had become become very faint and was experiencing intense pain in my left calve. I was diagnosed with DVT in my left leg.
25 2021-06-01 vaginal haemorrhage VAGINAL BLEEDING 5 DAYS AFTER CYCLE HAS ENDED; This spontaneous report received from a patient conc... Read more
VAGINAL BLEEDING 5 DAYS AFTER CYCLE HAS ENDED; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight was not reported and height was 66 inches. The patient's past medical history included spotting after cycle.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203a21a, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate, and venlafaxine hydrochloride. On 29-MAY-2021, the subject experienced vaginal bleeding 5 days after cycle has ended. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from vaginal bleeding 5 days after cycle has ended. This report was non-serious.
25 2021-07-12 fluid around the heart 3 weeks and a few days after the day I got my shot, i started experiencing tachycardia and shortness... Read more
3 weeks and a few days after the day I got my shot, i started experiencing tachycardia and shortness of breath. I went to my cardiologist and he prescribed and Echocardiogram and ecg. The Echocardiogram showed that I was experiencing pericarditis with Pericardial effusion and my eco showed a sinus tachycardia.
25 2021-07-19 blood clot Blood clotting